Regulatory, safety and economic considerations of over-the-counter medicines in the Indian population.

Background and purpose of review: Over-the-counter (OTC) medication has been an integral component of an established health care system but their easy accessibility might pose significant risks. This review has attempted to highlight the present scenario of OTC utilization in India, regarding standard practices followed globally. An attempt has also been made to highlight the lifecycle of a prescription and OTC medicine and the benefits and regulatory process involved in the prescription-to-OTC switch. Findings: A paradigm shift has been observed in self-medication practice with OTC medicines in recent times and has become a widespread practice worldwide. Numerous key drivers, such as increasing consumer awareness, broader consumer access to essential medication, and socio-economic benefits to the public health care system, have advocated this practice. On the other hand, self-medication using OTC is also inextricably linked with inevitable risks such as excessive drug dosage, polypharmacy, drug abuse, and drug interactions. Nevertheless, these issues could be further regulated by employing a defined OTC framework. The government of India has recognized the utmost need to develop a robust policy framework for the effective utilization of OTC drugs. Also, various initiatives toward modifying existing laws or developing new OTC drug policies has been taken. Conclusion: Prioritizing the utmost safety of the consumers and evident need of strong regulatory framework with respect to OTC drugs, the term "OTC" has been recommended as a distinct category of drugs by Government of India. This review has highlighted various factors that can play an essential role in OTC utilization and can be considered during policy reformation.

Antacids revisited: review on contemporary facts and relevance for self-management.

Heartburn and acid regurgitation are the typical symptoms of gastroesophageal reflux. Despite the availability of several treatment options, antacids remain the mainstay treatment for gastroesophageal reflux-related symptoms based on their efficacy, safety, and over-the-counter availability. Antacids are generally recommended for adults and children at least 12 years old, and the FDA recommends antacids as the first-line treatment for heartburn in pregnancy. This narrative review summarizes the mechanism, features, and limitations related to different antacid ingredients and techniques available to study the acid neutralization and buffering capacity of antacid formulations. Using supporting clinical evidence for different antacid ingredients, it also discusses the importance of antacids as OTC medicines and first-line therapies for heartburn, particularly in the era of the COVID-19 pandemic, in which reliance on self-care has increased. The review will also assist pharmacists and other healthcare professionals in helping individuals with heartburn to make informed self-care decisions and educating them to ensure that antacids are used in an optimal, safe, and effective manner.

Cinnarizine: A Contemporary Review.

Cinnarizine, is approved for nausea, vomiting, motion sickness, inner ear disorders and is considered as first-line pharmacotherapy for management of vertigo. It acts by anti-vasoconstrictor activity, reducing blood viscosity and reducing nystagmus in labyrinth. Lack of adequate literature on clinical evidence of cinnarizine and its combination (dimenhydrinate) in vertigo management prompted this review. A specific MEDLINE literature search strategy was designed combining Medical Subject Headings, free-text keywords (like cinnarizine and vertigo) using Boolean operators (1970-2016) for clinical studies, clinical reviews and meta-analyses of cinnarizine. Analyses of studies validated cinnarizine's efficacy in peripheral and central vertigo versus placebo or other therapies, and was well-tolerated by the patients recruited across different studies. Cinnarizine and/ or its combinations are favorable in management of vestibular disorders wherein cinnarizine acts predominantly peripherally on labyrinth and dimenhydrinate acts centrally on vestibular nuclei and associated centers in brainstem. Combination therapy of cinnarizine and/ or its combinations demonstrated a better safety profile than either of the mono-components, offering a viable therapeutic option in vertigo management.

Second-line injectable induced ototoxicity in drug resistant tuberculosis: A systematic review of Indian studies.

Second-line injectables (SLIs) form an essential class of agents in the treatment of drug resistant (DR) tuberculosis (TB). However, their use is sometimes limited due to serious adverse events like ototoxicity and hearing loss, leading to permanent hearing loss if SLIs are continued. Globally as well as in India a wide variation in incidence of ototoxicity/hearing loss has been reported in patients with DR-TB. In this systematic analysis, we attempt to ascertain the ototoxicity of SLIs in Indian patients with multidrug resistant tuberculosis (MDR-TB) wherein ototoxicity onset was assessed using audiometry performed at both pre- and post-SLI treatment initiation. Twenty two studies were identified based on the inclusion criteria. Ototoxicity was observed in 10.12% [349/3447] patients within 3.8 ± 2.6 months of treatment initiation when the ototoxicity was assessed either with or without audiometry assessment. Only five studies reported ototoxicity assessment with PTA at both pre- and post-SLI initiation and ototoxicity was observed in 27.01% (121/448) patients in these five studies. Sensorineural loss was observed in three studies (high frequency loss: capreomycin, 25.0% [1/4 patients]; amikacin, 19.7% [12/61]; kanamycin, 13.3% [22/166]; streptomycin, 11.8% [2/17]; flat loss: amikacin, 8.2% [5/61]; streptomycin, 5.9% [1/17]; kanamycin 4.8% [8/166]). Most of the patients experiencing ototoxicity were managed by discontinuing (49.6% [120/242]) or replacing SLI treatment (40.8% [49/120]). The study identified high prevalence of ototoxicity in Indian patients with DR-TB treated with SLI when ototoxicity was monitored regularly using PTA (27.01%), warranting a need to develop unified guidelines for monitoring ototoxicity, improving physician awareness and educating patients/caregivers for reporting symptoms of hearing loss.

Prevalence of drug-resistant pulmonary tuberculosis in India: systematic review and meta-analysis.

BACKGROUND: Drug-resistant pulmonary tuberculosis (DR-TB) is a significant public health issue that considerably deters the ongoing TB control efforts in India. The purpose of this review was to investigate the prevalence of DR-TB and understand the regional variation in resistance pattern across India from 1995 to 2015, based on a large body of published epidemiological studies. METHODS: A systematic review of published studies reporting prevalence of DR-TB from biomedical databases (PubMed and IndMed) was conducted. Meta-analysis was performed using random effects model and the pooled prevalence estimate (95% confidence interval [CI]) of DR-TB, multidrug resistant (MDR-) TB, pre-extensively drug-resistant (pre-XDR) TB and XDR-TB were calculated across two study periods (decade 1: 1995 to 2005; decade 2: 2006 to 2015), countrywide and in different regions. Heterogeneity in this meta-analysis was assessed using I2 statistic. RESULTS: A total of 75 of 635 screened studies that fulfilled the inclusion criteria were selected. Over 40% of 45,076 isolates suspected for resistance to any first-line anti-TB drugs tested positive. Comparative analysis revealed a worsening trend in DR-TB between the two study decades (decade 1: 37.7% [95% CI = 29.0; 46.4], n = 25 vs decade 2: 46.1% [95% CI = 39.0; 53.2], n = 36). The pooled estimate of MDR-TB resistance was higher in previously treated patients (decade 1: 29.8% [95% CI = 20.7; 39.0], n = 13; decade 2: 35.8% [95% CI = 29.2; 42.4], n = 24) as compared with the newly diagnosed cases (decade 1: 4.1% [95% CI = 2.7; 5.6], n = 13; decade 2: 5.6% [95% CI = 3.8; 7.4], n = 17). Overall, studies from Western states of India reported highest prevalence of DR-TB (57.8% [95% CI = 37.4; 78.2], n = 6) and MDR-TB (39.9% [95% CI = 21.7; 58.0], n = 6) during decade 2. Prevalence of pre-XDR TB was 7.9% (95% CI = 4.4; 11.4, n = 5) with resistance to fluoroquinolone (66.3% [95% CI = 58.2; 74.4], n = 5) being the highest. The prevalence of XDR-TB was 1.9% (95% CI = 1.2; 2.6, n = 14) over the 20-year period. CONCLUSION: The alarming increase in the trend of anti-TB drug resistance in India warrants the need for a structured nationwide surveillance to assist the National TB Control Program in strengthening treatment strategies for improved outcomes.

Effects of oral versus long-acting antipsychotics on social functioning: A psychiatrists' survey in India.

BACKGROUND: Schizophrenia is associated with functional challenges for patients; relapses in schizophrenia may lead to increased treatment costs and poor quality of life. OBJECTIVE: This SUSTAIN-I study was conducted to establish psychiatrists' perspective on impact of long-acting injectables (LAIs) antipsychotics on the socio-economic and functional burden of schizophrenia. METHODS: This cross-sectional, survey-based study was conducted in 5 cities in India. Psychiatrists (≥5years of experience) working in clinics, psychiatric, government hospitals and rehabilitation centers were included and administered a specially designed questionnaire to elicit information on their clinical practice and prescription patterns. Perceived treatment costs for LAI versus oral antipsychotic treatments (OATs) and relapse rates were assessed. Descriptive statistics were used to summarize results. RESULTS: Total 31 physicians completed this survey. In acute phase, OAT prescription was higher whereas chronic patients were treated with either OATs or LAIs. Treatment with LAIs was the preferred treatment in 9% of chronic cases. Reduced relapse rates were observed with LAI treatment: 12% patients on LAIs relapsed as compared with 60% patients on OATs. Monthly medication cost for oral medications was lower ($8-$17) than short-acting injectables ($22-$50). For chronic cases, atypical antipsychotics cost (oral: $11.7-25, LAI: $150-167) was higher than typical antipsychotics (oral: $4-5, LAI: $5-25). Of the total expenses incurred, cost for hospital admissions was the largest component (78%). CONCLUSION: Despite enhanced treatment adherence and potential to lower risk of rehospitalizations from relapse, LAIs are not the preferred treatment choice for patients with schizophrenia in India, owing to their perceived high costs.

Addressing the barriers related with opioid therapy for management of chronic pain in India.

India has a high prevalence of chronic disorders which may be associated with persistent pain. Despite the availability of multiple treatment options, chronic pain is largely untreated and contributes to disability and mortality. Medical consumption of opioids remains low due to various barriers that prevent access to opioids for patients and healthcare practitioners. Stringent regulatory provisions outlined in the Narcotic Drugs and Psychotropic Substances Act (1985) have been major deterrents to adequate opioid use. Although multiple amendments to the act have ensured ease of opioid access for medicinal purposes, concerns such as lack of awareness and prescribing practices and attitudes of physicians/patients still need to be addressed. This review aims to identify these barriers and suggest recommendations to overcome them.

Evidence and consensus recommendations for the pharmacological management of pain in India.

Despite enormous progress in the field of pain management over the recent years, pain continues to be a highly prevalent medical condition worldwide. In the developing countries, pain is often an undertreated and neglected aspect of treatment. Awareness issues and several misconceptions associated with the use of analgesics, fear of adverse events - particularly with opioids and surgical methods of analgesia - are major factors contributing to suboptimal treatment of pain. Untreated pain, as a consequence, is associated with disability, loss of income, unemployment and considerable mortality; besides contributing majorly to the economic burden on the society and the health care system in general. Available guidelines suggest that a strategic treatment approach may be helpful for physicians in managing pain in real-world settings. The aim of this manuscript is to propose treatment recommendations for the management of different types of pain, based on the available evidence. Evidence search was performed by using MEDLINE (by PubMed) and Cochrane databases. The types of articles included in this review were based on randomized control studies, case-control or cohort studies, prospective and retrospective studies, systematic reviews, meta-analyses, clinical practice guidelines and evidence-based consensus recommendations. Articles were reviewed by a multidisciplinary expert panel and recommendations were developed. A stepwise treatment algorithm-based approach based on a careful diagnosis and evaluation of the underlying disease, associated comorbidities and type/duration of pain is proposed to assist general practitioners, physicians and pain specialists in clinical decision making.

Usage pattern, glycemic improvement, hypoglycemia, and body mass index changes with sulfonylureas in real-life clinical practice: results from OBSTACLE Hypoglycemia Study.

BACKGROUND: Individual sulfonylurea agents differ in pharmacokinetic properties and clinical effects. This study aimed to describe the usage pattern, glycemic improvement, hypoglycemia, and change in body mass index (BMI) observed with commonly used sulfonylureas. SUBJECTS AND METHODS: Patients of either gender with type 2 diabetes mellitus (T2DM), between 18 and 75 years old and requiring addition of a sulfonylurea to an ongoing regimen of oral antihyperglycemic agent(s), were enrolled. Glycosylated hemoglobin (HbA1c) and BMI were assessed at both baseline and the end of 12 weeks of follow-up. The hypoglycemia score was assessed at the end of follow-up only. RESULTS: In total, 1,069 patients were enrolled in the study, of whom 950 were considered evaluable. After a mean follow-up of 14.34±2.80 weeks, the HbA1c level decreased by 0.86±2.28%, BMI increased by 0.13±0.78 kg/m2, and mean hypoglycemia score was 0.98±1.42. A weak negative, statistically significant correlation (r = -0.093; P=0.0044) between hypoglycemic scores and increase in BMI was observed. No correlation was observed between change in HbA1c level and change in BMI. Glimepiride was the most commonly prescribed sulfonylurea (75.3%). For patients on glimepiride, a weak positive, statistically significant correlation (r=0.098; P=0.0082) between its dose and the hypoglycemic score was observed. CONCLUSIONS: Various sulfonylurea agents appear to differ in their effect on glycemic control, tendency to cause hypoglycemia, and gain in BMI. Hypoglycemia caused by these agents appears not only to be dose related, but also correlates inversely with gain in BMI.